{ "FullStudy":{ "Rank":218210, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511302", "OrgStudyIdInfo":{ "OrgStudyId":"01.1.1.H2" }, "Organization":{ "OrgFullName":"Revalesio Corporation", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma", "OfficialTitle":"A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma" }, "StatusModule":{ "StatusVerifiedDate":"July 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 24, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 28, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Revalesio Corporation", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Asthma" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"65", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"RNS60-BD 0.25", "ArmGroupType":"Experimental", "ArmGroupDescription":"RNS60 in combination with Budesonide 0.25mg/2ml concentration", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RNS60", "Drug: Budesonide" ] } },{ "ArmGroupLabel":"RNS60-BD 0.5", "ArmGroupType":"Experimental", "ArmGroupDescription":"RNS60 in combination with Budesonide 0.5mg/2ml concentration", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RNS60", "Drug: Budesonide" ] } },{ "ArmGroupLabel":"NS-BD 0.5", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Normal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Normal Saline", "Drug: Budesonide" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"RNS60", "InterventionDescription":"RNS60, 2ml, nebulized twice daily.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "RNS60-BD 0.25", "RNS60-BD 0.5" ] } },{ "InterventionType":"Drug", "InterventionName":"Normal Saline", "InterventionDescription":"Normal Saline placebo, 2 ml, nebulized twice daily.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "NS-BD 0.5" ] } },{ "InterventionType":"Drug", "InterventionName":"Budesonide", "InterventionDescription":"Budesonide, in either 0.25 mg or 0.5 mg per 2 ml concentration in liquid suspension, nebulized once per day in combination with RNS60 or NS.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "NS-BD 0.5", "RNS60-BD 0.25", "RNS60-BD 0.5" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Forced expiratory volume in 1 second (FEV1)", "PrimaryOutcomeDescription":"Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores.", "PrimaryOutcomeTimeFrame":"Baseline to 56 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in peak expiratory flow", "SecondaryOutcomeDescription":"Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by daily peak expiratory flow values.", "SecondaryOutcomeTimeFrame":"Baseline to 56 days" },{ "SecondaryOutcomeMeasure":"Change in quality of life", "SecondaryOutcomeDescription":"Evidence that RNS60 in combination with budesonide does not reduce patient's quality of life, as measured by weekly QOL questionnaire over 28 days.", "SecondaryOutcomeTimeFrame":"56 days" },{ "SecondaryOutcomeMeasure":"Change in rescue inhaler usage", "SecondaryOutcomeDescription":"Evidence that RNS60 in combination with budesonide does not increase rescue inhaler usage, as measured by patient diary.", "SecondaryOutcomeTimeFrame":"56 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or female non-smokers, aged between 18 and 65 years.\nClinical diagnosis of mild to moderate asthma meeting NHLBI 2007 guidelines as outlined in Appendix A.\nSubjects who have a currently prescribed inhaled corticosteroid medication to treat asthma, alone or in combination with other medications, with usage of 1 month (≥ 95% compliance) or more on the inhaled corticosteroid treatment.\nNormal 12-lead ECG at Screening.\nNormal single view chest x-ray at Screening.\nMen and women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment (Day 57).\nWomen of childbearing potential who have a negative pregnancy test (serum HCG) at the time of study entry, and again on Day 22.\nSubjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary, informed consent.\n\nExclusion Criteria:\n\nChronic or acute disease that might interfere with the evaluation of RNS60.\nPregnancy, intent to become pregnant, or breastfeeding.\nCurrent or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated).\nPositive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody.\nPositive urine drug screen (UDS) for drugs of abuse including alcohol and cotinine at the time of study entry and again on Day 22.\nInfections that require intravenous antibiotic therapy.\nSignificant organ dysfunction, including cardiac, renal, liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry.\nTreatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry.\nTreatment with any investigational drugs, therapies, or medical devices within 4 weeks prior to study entry.\nAny use of antidepressants or other psychiatric medicine within 4 weeks prior to study entry and/or during the study treatment period.\nUse of any over-the-counter asthma treatments, including Primatene Mist, during the 8-week active study period.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"West Coast Clinical Trials", "LocationCity":"Costa Mesa", "LocationState":"California", "LocationZip":"92626", "LocationCountry":"United States" },{ "LocationFacility":"California Allergy and Asthma", "LocationCity":"Los Angeles", "LocationState":"California", "LocationZip":"90025", "LocationCountry":"United States" },{ "LocationFacility":"Axis Clinical Trials", "LocationCity":"Los Angeles", "LocationState":"California", "LocationZip":"90036", "LocationCountry":"United States" },{ "LocationFacility":"Integrated Research Group", "LocationCity":"Riverside", "LocationState":"California", "LocationZip":"92506", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000019819", "InterventionMeshTerm":"Budesonide" },{ "InterventionMeshId":"C000627108", "InterventionMeshTerm":"RNS60" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000893", "InterventionAncestorTerm":"Anti-Inflammatory Agents" },{ "InterventionAncestorId":"D000001993", "InterventionAncestorTerm":"Bronchodilator Agents" },{ "InterventionAncestorId":"D000001337", "InterventionAncestorTerm":"Autonomic Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000018927", "InterventionAncestorTerm":"Anti-Asthmatic Agents" },{ "InterventionAncestorId":"D000019141", "InterventionAncestorTerm":"Respiratory System Agents" },{ "InterventionAncestorId":"D000005938", "InterventionAncestorTerm":"Glucocorticoids" },{ "InterventionAncestorId":"D000006728", "InterventionAncestorTerm":"Hormones" },{ "InterventionAncestorId":"D000006730", "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists" },{ "InterventionAncestorId":"D000000894", "InterventionAncestorTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ "InterventionAncestorId":"D000018712", "InterventionAncestorTerm":"Analgesics, Non-Narcotic" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" },{ "InterventionAncestorId":"D000019999", "InterventionAncestorTerm":"Pharmaceutical Solutions" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M20295", "InterventionBrowseLeafName":"Budesonide", "InterventionBrowseLeafAsFound":"Budesonide", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M268799", "InterventionBrowseLeafName":"RNS60", "InterventionBrowseLeafAsFound":"RNS60", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2798", "InterventionBrowseLeafName":"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3851", "InterventionBrowseLeafName":"Bronchodilator Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19547", "InterventionBrowseLeafName":"Anti-Asthmatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19721", "InterventionBrowseLeafName":"Respiratory System Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7630", "InterventionBrowseLeafName":"Glucocorticoids", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8371", "InterventionBrowseLeafName":"Hormone Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2799", "InterventionBrowseLeafName":"Anti-Inflammatory Agents, Non-Steroidal", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19370", "InterventionBrowseLeafName":"Analgesics, Non-Narcotic", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19188", "InterventionBrowseLeafName":"Antirheumatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M20444", "InterventionBrowseLeafName":"Pharmaceutical Solutions", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"Resp", "InterventionBrowseBranchName":"Respiratory System Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"PhSol", "InterventionBrowseBranchName":"Pharmaceutical Solutions" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001249", "ConditionMeshTerm":"Asthma" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001982", "ConditionAncestorTerm":"Bronchial Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000008173", "ConditionAncestorTerm":"Lung Diseases, Obstructive" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012130", "ConditionAncestorTerm":"Respiratory Hypersensitivity" },{ "ConditionAncestorId":"D000006969", "ConditionAncestorTerm":"Hypersensitivity, Immediate" },{ "ConditionAncestorId":"D000006967", "ConditionAncestorTerm":"Hypersensitivity" },{ "ConditionAncestorId":"D000007154", "ConditionAncestorTerm":"Immune System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M25724", "ConditionBrowseLeafName":"Respiratory Aspiration", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3137", "ConditionBrowseLeafName":"Asthma", "ConditionBrowseLeafAsFound":"Asthma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3840", "ConditionBrowseLeafName":"Bronchial Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9753", "ConditionBrowseLeafName":"Lung Diseases, Obstructive", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8601", "ConditionBrowseLeafName":"Hypersensitivity", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13550", "ConditionBrowseLeafName":"Respiratory Hypersensitivity", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8603", "ConditionBrowseLeafName":"Hypersensitivity, Immediate", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8783", "ConditionBrowseLeafName":"Immune System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" } ] } } } } } }